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Pessary to Prevent Prematurity in Twins in Case of Short Cervix (PESSAR'ONE)

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ClinicalTrials.gov Identifier: NCT02328989
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
For 25 years, the twin pregnancy rate has regularly increased in the majority of European countries and in the United States, by 35% between 1981 and 2006. Increased use of medically assisted procreation and older maternal age are the two main causes. At the present time twin pregnancies represent nearly 20% of premature deliveries. The rate of very premature births (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is the principal cause of neonatal mortality and of brain sequelae in twins, the search for a preventive treatment appears as a priority in perinatal medicine. The investigators recently showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a better predictive investigation of premature delivery < 34 wks than digital examination. Recently in a randomized trial in a population of short-cervix singleton pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with the usual management group. No other trial of pessary use in short-cervix twin pregnancies was published today. Recently, in a historical comparison of twins with twin-to-twin transfusion syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery with the use of pessary in case of short cervix. The investigators wish to set up a randomized multicenter study in France in the population of short-cervix twin pregnancies to show a potential benefit of the pessary compared with simple surveillance.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Pessary Not Applicable

Detailed Description:
For 25 years, the twin pregnancy rate has regularly increased in the majority of European countries and in the United States, by 35% between 1981 and 2006. Increased use of medically assisted procreation and older maternal age are the two main causes. At the present time twin pregnancies represent nearly 20% of premature deliveries. The rate of very premature births (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is the principal cause of neonatal mortality and of brain sequelae in twins, the search for a preventive treatment appears as a priority in perinatal medicine. The investigators recently showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a better predictive investigation of premature delivery < 34 wks than digital examination.[1] As there is currently no recommended preventive treatment for prematurity in twin pregnancies[2], the 2009 guidelines of the College of Obstetricians leave the teams with the option of carrying out systematic cervical ultrasound or not during follow-up investigations.[3] Recently in a randomized trial in a population of short-cervix singleton pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with the usual management group.[4] In a recent multicenter trial (ProTWIN), while therapeutic efficacy of the pessary (versus usual management) was not demonstrated in the overall group of twin pregnancies, in the short-cervix subgroup (< 25th percentile of the population) the < 32 wks delivery rate decreased from 29% to 14% (OR= 0.49 (0.24-0.97) and neonatal morbidity also decreased.[5] No other trial of pessary use in short-cervix twin pregnancies was published today. Recently, in a historical comparison of twins with twin-to-twin transfusion syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery with the use of pessary in case of short cervix.[6] The investigators wish to set up a randomized multicenter study in France in the population of short-cervix twin pregnancies to show a potential benefit of the pessary compared with simple surveillance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pessary to Prevent Prematurity in Twins in Case of Short Cervix
Study Start Date : November 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Pessary
The device will be placed in the vagina during the consultation. It is rinsed in sterile water for lubrification and left in place until delivery or remove at 36 weeks in case of no delivery before. There is no need to use any analgesia. The good position of the pessary is checking in the same time than the placement with digital examination.
Device: Pessary
The device will be placed in the vagina during the consultation. It is rinsed in sterile water for lubrification and left in place until delivery or remove at 36 weeks in case of no delivery before. There is no need to use any analgesia. The good position of the pessary is checking in the same time than the placement with digital examination.

No Intervention: No pessary
No pessary will be placed in the vagina.



Primary Outcome Measures :
  1. perinatal death or significant neonatal morbidity until discharge from the hospital [ Time Frame: 6 months ]
    it's a composite outcome : perinatal death (i.e medical interruption of pregnancy, intrauterine fetal death, or death occurring during the first four weeks after birth, before day 29), or significant neonatal morbidity until discharge from the hospital, defined as one or more of the following complications: bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH) grade III or IV, periventricular leucomalacia (PVL), necrotizing enterocolitis (NEC) grade II or higher, culture proven sepsis, retinopathy of prematurity (ROP) requiring treatment.


Secondary Outcome Measures :
  1. Preterm delivery [ Time Frame: 6 months ]
  2. To evaluate the prolongation of pregnancy in days [ Time Frame: 6 months ]
  3. The differential cost-efficacy ratio of the two strategies [ Time Frame: 6 months ]
  4. Tolerance of the pessary [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Asymptomatic twin pregnancies between 16 and 24+0 weeks CL < 25th percentile for GA

- < 35mm between 16 and 24+0d weeks Vaginal swabs for bacteriological analysis < 72 hours Patient age > 18 years Written informed consent obtained French first language (speak, read, understand) French social security cover

Exclusion Criteria:

  • Painful regular contractions
  • Major fetal abnormalities
  • Fetal malformation
  • Active vaginal bleeding, placenta praevia
  • Discordance fetal weight more than 40%
  • Treatment with progesterone
  • Patient with cerclage
  • Ruptured of membrane
  • Twin to twin transfusion syndrome
  • Uterine malformation
  • Chronic maternal disease (diabetes, hypertension, renal insufficiency, Heparin Treatment)
  • Conisation history
  • patients subject to a judicial safeguard order, participating in another research study including an exclusion period which has not expired at the time of screening will not be included

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328989


Locations
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Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: Christophe Vayssière, PhD CHU Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02328989    
Other Study ID Numbers: 13 7048 01
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
prematurity
short cervix
twin pregnancy
pessary
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications